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What you need to know before you take Roaccutane

Do not take Roaccutane: · If you are pregnant or breast-feeding · If there is any chance you could become pregnant, you must follow the precautions under “Pregnancy prevention programme”, see section on “Warnings and precautions”. · If you are allergic to isotretinoin, peanut or soya or any other ingredients of this medicine (listed in section 6). · If you have liver disease · If you have very high levels of blood fats (e.g. high cholesterol or triglycerides) · If you have very high levels of vitamin A in your body (hypervitaminosis A) · If you are receiving treatment with tetracyclines (a type of antibiotic) at the same time (see “Other medicines and Roaccutane”) If any of these apply to you, go back to your doctor before taking any Roaccutane. Warnings and precautions Talk to your doctor or pharmacist before taking Roaccutane: · If you have ever had any kind of mental health problems. This includes depression, aggressive tendencies or mood changes. It also includes thoughts about hurting yourself or ending your life. This is because your mood may be affected while taking Roaccutane. Your doctor will discuss how best to monitor your mental health during your treatment. Talk to your doctor if you experience persistent pain in your lower back or buttocks during treatment with Roaccutane. These symptoms may be signs of sacroiliitis, a type of inflammatory back pain. Your doctor may discontinue treatment with Roaccutane and refer you to a specialist for treatment of inflammatory back pain. Further evaluation may be needed including imaging modalities such as MRI. Pregnancy prevention programme Women who are pregnant must not take Roaccutane This medicine can seriously harm an unborn baby (the medicine is said to be ‘teratogenic’) – it can cause serious abnormalities of the unborn baby’s brain, face, ear, eye, heart and certain glands (thymus gland and parathyroid gland). It also makes a miscarriage more likely. This may happen even if Roaccutane is taken only for a short time during pregnancy. • You must not take Roaccutane if you are pregnant or if you think you might be pregnant. • You must not take Roaccutane if you are breastfeeding. The medicine is likely to pass into your milk and may harm your baby. • You must not take Roaccutane if you could get pregnant during treatment. • You must not get pregnant for one month after stopping this treatment because some medicine may still be left in your body. Women who could get pregnant are prescribed Roaccutane under strict rules. This is because of the risk of serious harm to the unborn baby These are the rules: 3 uk-pl-roaccutane-clean-230929-10mg-20mg-caps eMC • Your doctor must explain the risk of harm to the unborn baby – you must understand why you must not get pregnant and what you need to do to prevent getting pregnant. • You must have talked about contraception (birth control) with your doctor. The doctor will give you information on how not to get pregnant. The doctor may send you to a specialist for contraception advice. • Before you start treatment, your doctor will ask you to take a pregnancy test. The test must show that you are not pregnant when starting treatment with Roaccutane. Women must use effective contraception before, during and after taking Roaccutane · You must agree to use at least one very reliable method of contraception (for example an intra uterine device or contraceptive implant) or, two effective methods that work in different ways (for example a hormonal contraceptive pill and a condom). Discuss with your doctor which methods would be suitable for you. · You must use contraception for a month before taking Roaccutane, during treatment and for a month afterwards. · You must use contraception even if you do not have periods or you are not sexually active (unless your doctor decides this is not necessary). Women must agree to pregnancy testing before, during and after taking Roaccutane • You must agree to regular follow-up visits, ideally every month. • You must agree to have regular pregnancy tests, ideally every month during treatment and, because some medicine may still be left in your body, 1 month after stopping Roaccutane (unless your doctor decides this is not necessary in your case). • You must agree to extra pregnancy tests if your doctor asks you. • You must not get pregnant during treatment or for a month afterwards because some medicine may still be left in your body. • Your doctor will discuss all these points with you, using a checklist and will ask you (or a parent/guardian) to sign it. This form confirms that you have been told about the risks and that you will follow the rules above. If you get pregnant while taking Roaccutane, stop taking the medicine straight away, and contact your doctor. Your doctor may send you to a specialist for advice. Also, if you become pregnant within one month after you stop taking Roaccutane, you should contact your doctor. Your doctor may send you to a specialist for advice. Your doctor has written information on pregnancy prevention for the users of Roaccutane which should be given to you. A new prescription is needed for more treatment. Each prescription is only valid for 7 days. Advice for men The levels of oral retinoid in the semen of men taking Roaccutane are too low to harm their partners’ unborn baby. However, you must never share your medication with anyone. Additional precautions You should never give this medicinal product to another person. Please take any unused capsules to your pharmacist at the end of treatment. You should not donate blood during treatment with this medicine and for 1 month after stopping Roaccutane because an unborn baby could be harmed if a pregnant patient receives your blood. 4 uk-pl-roaccutane-clean-230929-10mg-20mg-caps eMC Mental health problems You may not notice some changes in your mood and behaviour and so it is very important that you tell your friends and family that you are taking this medicine. They may notice these changes and help you quickly identify any problems that you need to talk to your doctor about. Advice for all patients · Tell your doctor if you have ever had any mental illness (including depression, suicidal behaviour or psychosis), or if you take medicines for any of these conditions. · Severe Skin reactions (e.g. erythema multiforme (EM), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)) have been reported with the use of Roaccutane. The rash may progress to widespread blistering or peeling of the skin. You should also look for ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). · Rarely, Roaccutane may cause severe allergic reactions some of which can affect skin in the form of eczema, hives and bruises or red patches on arms and legs. If you develop an allergic reaction, stop taking Roaccutane, seek urgent advice from a doctor and tell him that you are taking this medicine. · Cut down on intensive exercise and physical activity. Roaccutane can cause muscle and joint pain particularly in children and teenagers undertaking vigorous physical activity. · Roaccutane has been associated with inflammatory bowel disease. Your doctor will take you off Roaccutane if you have severe bloody diarrhoea without any history of gastrointestinal disorders. · Roaccutane may cause dry eyes, intolerance to contact lenses and visual difficulties including decreased night vision. Cases of dry eyes not resolving after discontinuation of therapy have been reported. Tell your doctor if you have any of these symptoms. Your doctor may ask you to use lubricating eye ointment or tear replacement therapy. If you use contact lenses and you have developed intolerance to contact lenses, you may be advised to wear glasses during the treatment. Your doctor may refer you to a specialist for advice if you develop visual difficulties and you may be asked to stop taking Roaccutane. · Benign intracranial hypertension has been reported with Roaccutane use and in some cases where Roaccutane was used together with tetracyclines (a type of antibiotic). Stop taking Roaccutane and seek urgent advice from your doctor if you develop symptoms like headache, nausea, vomiting and visual disturbances. Your doctor may refer you to a specialist to check for swelling of optic disk in the eye (papilloedema). · Roaccutane may increase liver enzyme levels. Your doctor will do blood tests before, during and after Roaccutane treatment to check these levels. If they stay high, your doctor may lower your dose or take you off Roaccutane. · Roaccutane commonly increases blood fats, such as cholesterol or triglycerides. Your doctor will test these levels before, during and after Roaccutane treatment. It is best that you do not drink alcoholic drinks or that you at least reduce the amount you usually drink while on treatment. Tell your doctor if you already have high blood fats, diabetes (high blood sugars), are overweight, or an alcoholic. You may need blood tests more often. If your blood fats stay high, your doctor may lower your dose, or take you off Roaccutane. · Tell your doctor if you have any kidney problems. Your doctor may start you on a lower dose of Roaccutane and then increase it to the maximum tolerated dose. · Roaccutane may increase blood sugar levels. In rare cases, people become diabetic. Your doctor may monitor blood sugar levels during treatment, particularly if you already have diabetes, are overweight, or are an alcoholic. · Your skin is likely to get dry. Use a skin moisturising ointment or cream and a lip balm during treatment. To prevent skin irritation you should avoid using exfoliating or anti-acne products. · Avoid too much sun and do not use a sun-lamp or sun-bed. Your skin may become more sensitive to sunlight. Before you go out in the sun, use a sun-protection product with a high protection factor (SPF 15 or higher). · Don’t have any cosmetic skin treatments. Roaccutane may make your skin more fragile. Don’t have any waxing (hair removal), dermabrasion or laser treatments (removing horny skin 5 uk-pl-roaccutane-clean-230929-10mg-20mg-caps eMC or scars) during treatment, or for at least 6 months after treatment. They could cause scarring, skin irritation, or rarely, changes in the colour of your skin. · Isotretinoin has been associated with sexual problems. These include problems getting or maintaining an erection, lower libido, vaginal dryness, orgasm difficulties and reduced sensation in the genitals. There have been reports of long-lasting sexual problems where the symptoms have continued despite stopping treatment with isotretinoin. Talk to your doctor if you experience any sexual problems during treatment. Children and adolescents The use of Roaccutane in children under the age of 12 is not recommended. This is because it is not known if it is safe or effective in this age group. Roaccutane should not be used to treat prepubertal acne and not in children aged less than 12 years of age. If you are aged under 18 years of age, you must not take Roaccutane unless two prescribers have agreed that your condition does not respond adequately to other treatments and the benefits of treatment outweigh the risks. Other medicines and Roaccutane Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including herbal and non-prescription products. · Do not take vitamin A supplements or tetracyclines (a type of antibiotic), or use any skin treatments for acne while you are on Roaccutane. It is fine to use moisturisers and emollients (skin creams or preparations that prevent water loss and have a softening effect on the skin). · Avoid the use of topical keratolytic or exfoliative anti-acne agents while you are on Roaccutane. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. For more information on contraception, pregnancy and breast-feeding, see section 2 “Pregnancy prevention programme”. Driving and using machines You may not see as well at night during your treatment. This can happen suddenly. In rare cases this has continued after the treatment has stopped. Drowsiness and dizziness have been reported very rarely. If this happens to you, you should not drive or operate machinery. Roaccutane contains sorbitol and soya-bean oil This medicine contains 2.00 mg – 3.05 mg sorbitol in each 10 mg capsule. This medicine contains 3.20 mg – 4.86 mg sorbitol in each 20 mg capsule. If you are allergic to peanut or soya, do not use this medicine.